Weekly Exenatide Therapy: A Real-World Comparison of Incretin Therapies.

Background: Traditional diabetes therapies have been associated with weight gain, hypoglycemia, and/or high secondary failure rates. Glucagon-like peptide-1 (GLP-1) analog use is associated with a minimal risk of hypoglycemia, a persistent average weight loss of 2 to 3 kg, and sustained efficacy even after 3 years of use. Presently, 3 GLP-1 analogs are commercially available in the United States. Objective: To evaluate the real-world clinical utility of once weekly exenatide in type 2 diabetes mellitus (T2DM) patients who previously received once or twice daily GLP-1 therapy. Methods: In this pre-post observational study, electronic medical records (EMRs) were reviewed to identify patients meeting all study criteria. Data collected included baseline patient demographic information, duration of diabetes, disease states, medications, pertinent laboratory data, blood pressure, height, weight, and reported adverse drug events. Primary (changes in A1C and percentage of patients reporting adverse effects of therapy) and secondary (percentage of patients with A1C of <7% and changes in weight, blood pressure, and lipids) outcomes were evaluated using appropriate statistical analysis. Results: EMRs of 78 patients met all study criteria. Baseline patient demographic information included an average age of 61 ± 12 years, an average duration of T2DM of 14 ± 6 years, 59% of patients were male, and 93.6% were Caucasian. The baseline average body mass index was 39 ± 9.2, and mean A1C was 7.47 ± 1.45%. After a minimum of 3 months (average = 5.6 months) switchover, there were significant decreases in A1C (-0.35%; P = .0067) and weight (-1.6 kg; P = .0151). There were no significant changes in blood pressure or lipid levels. Two patients (2.5%) discontinued once weekly exenatide due to adverse reactions. Conclusion: Once weekly exenatide was generally well tolerated and significantly reduced A1C levels and body weight in patients with T2DM when switched from a shorter-acting GLP-1 analog.

A glucose meter accuracy and precision comparison: the FreeStyle Flash Versus the Accu-Chek Advantage, Accu-Chek Compact Plus, Ascensia Contour, and the BD Logic.

BACKGROUND: This study compared the accuracy and precision of five blood glucose (BG) meters. METHODS: Diabetes patients undergoing venipuncture for glucose testing were randomized to one of two groups consisting of three meters: FreeStyle Flash (Abbott Diabetes Care, Alameda, CA), Accu-Chek Advantage (Roche Diagnostics Corp., Indianapolis, IN), and Accu-Chek Compact Plus (Roche Diagnostics) or FreeStyle Flash, Ascensia Contour (Bayer Healthcare, Diagnostic Division, Tarrytown, NY), and BD Logic (BD Diabetes Care, Franklin Lake, NJ). Within 5 min following venipuncture, duplicate finger BG measurements from three ipsilateral fingers were taken. Finger glucose measurements were compared with laboratory reference values. Accuracy was assessed by a Clarke error grid analysis (EGA) and within 10% of the laboratory value criteria. Meter precision was determined by calculating the absolute mean differences in glucose values between duplicate samples. RESULTS: Finger sticks were obtained from 202 patients. Mean venipuncture BG was 148 mg/dL (SD +/- mg/64 dL; range 25-439 mg/dL). Accuracy by Clarke EGA (Zone A results) was demonstrated in 69% of Advantage samples, 75% of Compact Plus, and 96% of the first group of Flash versus 88% of the Contour, 67% of the Logic, and 91% of the second Flash samples (P < 0.05 for both Flash and Contour). Meter accuracy using the 10% criteria was demonstrated in 30%, 38%, 70%, 46%, 48%, and 68% of the samples, respectively (P < 0.05 for both Flash groups compared to each of the other meters). There were no differences in meter precision. CONCLUSIONS: No statistically significant differences in accuracy were evident using the Clarke EGA criteria (pooled results of Zone A and B), though the more strict 20% accuracy criteria (Zone A results only) found the Flash and Contour to have significantly greater accuracy compared to the Advantage, Compact Plus, and the Logic. Using the 10% accuracy criteria found the Flash to have significantly greater accuracy than each of the other four meters. All five meters demonstrated similar precision.

Sensor-augmented insulin pump therapy: results of the first randomized treat-to-target study.

BACKGROUND: The objective of the study was to evaluate the clinical effectiveness and safety of a device that combines an insulin pump with real-time continuous glucose monitoring (CGM), compared to using an insulin pump with standard blood glucose monitoring systems. METHODS: This 6-month, randomized, multicenter, treat-to-target study enrolled 146 subjects treated with continuous subcutaneous insulin infusion between the ages of 12 and 72 years with type 1 diabetes and initial A1C levels of >or=7.5%. Subjects were randomized to pump therapy with real-time CGM (sensor group [SG]) or to pump therapy and self-monitoring of blood glucose only (control group [CG]). Clinical effectiveness and safety were evaluated. RESULTS: A1C levels decreased (P<0.001) from baseline (8.44+/-0.70%) in both groups (SG, -0.71+/-0.71%; CG, -0.56+/-0.072%); however, between-group differences did not achieve significance. SG subjects showed no change in mean hypoglycemia area under the curve (AUC), whereas CG subjects showed an increase (P=0.001) in hypoglycemia AUC during the blinded periods of the study. The between-group difference in hypoglycemia AUC was significant (P<0.0002). Greater than 60% sensor utilization was associated with A1C reduction (P=0.0456). Fourteen severe hypoglycemic events occurred (11 in the SG group and three in the CG group, P=0.04). CONCLUSIONS: A1C reduction was no different between the two groups. Subjects in the CG group had increased hypoglycemia AUC and number of events during blinded CGM use; however, there was no increase in hypoglycemia AUC or number of events in the SG group. Subjects with greater sensor utilization showed a greater improvement in A1C levels.

Efficacy of teriparatide in patients with resolved secondary hyperparathyroidism due to vitamin D deficiency.

OBJECTIVE: To determine the efficacy of at least 1 year of teriparatide therapy on bone mineral density (BMD), T-scores, and rates of occurrence of fractures in patients with a history of resolved secondary hyperparathyroidism due to vitamin D deficiency and to compare its efficacy with that in patients without a history of resolved secondary hyperparathyroidism. METHODS: In this retrospective study based on a search of electronic medical records, we collected the following data: patient demographics, doses of calcium and vitamin D supplementation, duration of teriparatide treatment, history and treatment of secondary hyperparathyroidism, BMD information, T-scores, and any history of fractures. Paired and unpaired t tests, the Fisher exact test, and the Wilcoxon rank sum test were used for statistical analysis. RESULTS: Ninety-five patients (7 with a history of resolved secondary hyperparathyroidism due to vitamin D deficiency and 88 without such a history) fulfilled the study inclusion criteria. Baseline characteristics (demographics, median calcium and vitamin D supplementation doses, mean BMD, mean T-scores, and fracture rates before teriparatide therapy) were similar between the 2 groups. In comparison with baseline data, after a mean of 21 months of teriparatide therapy: (1) hip BMD and T-scores did not change in either study group (with no significant differences between the 2 groups), (2) spine BMD and T-scores significantly improved in both study groups (with no significant differences between them), and (3) wrist T-scores significantly worsened in both study groups (with wrist BMD significantly lower in patients without a history of secondary hyperparathyroidism). No patients with a history of secondary hyperparathyroidism sustained a fracture while receiving teriparatide therapy versus 6 of 88 patients without a history of secondary hyperparathyroidism (P = .624). CONCLUSION: Patients with a history of resolved secondary hyperparathyroidism attributable to vitamin D deficiency responded to teriparatide therapy in a fashion similar to patients without such a history.

Accuracy and precision of four value-added blood glucose meters: the Abbott Optium, the DDI Prodigy, the HDI True Track, and the HypoGuard Assure Pro.

PURPOSE: This study compared the accuracy and precision of four value-added glucose meters. METHODS: Finger stick glucose measurements in diabetes patients were performed using the Abbott Diabetes Care (Alameda, CA) Optium, Diagnostic Devices, Inc. (Miami, FL) DDI Prodigy, Home Diagnostics, Inc. (Fort Lauderdale, FL) HDI True Track Smart System, and Arkray, USA (Minneapolis, MN) HypoGuard Assure Pro. Finger glucose measurements were compared with laboratory reference results. Accuracy was assessed by a Clarke error grid analysis (EGA), a Parkes EGA, and within 5%, 10%, 15%, and 20% of the laboratory value criteria (chi2 analysis). Meter precision was determined by calculating absolute mean differences in glucose values between duplicate samples (Kruskal-Wallis test). RESULTS: Finger sticks were obtained from 125 diabetes patients, of which 90.4% were Caucasian, 51.2% were female, 83.2% had type 2 diabetes, and average age of 59 years (SD 14 years). Mean venipuncture blood glucose was 151 mg/dL (SD +/-65 mg/dL; range, 58-474 mg/dL). Clinical accuracy by Clarke EGA was demonstrated in 94% of Optium, 82% of Prodigy, 61% of True Track, and 77% of the Assure Pro samples (P < 0.05 for Optium and True Track compared to all others). By Parkes EGA, the True Track was significantly less accurate than the other meters. Within 5% accuracy was achieved in 34%, 24%, 29%, and 13%, respectively (P < 0.05 for Optium, Prodigy, and Assure Pro compared to True Track). Within 10% accuracy was significantly greater for the Optium, Prodigy, and Assure Pro compared to True Track. Significantly more Optium results demonstrated within 15% and 20% accuracy compared to the other meter systems. The HDI True Track was significantly less precise than the other meter systems. CONCLUSIONS: The Abbott Optium was significantly more accurate than the other meter systems, whereas the HDI True Track was significantly less accurate and less precise compared to the other meter systems.

Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus.

OBJECTIVE: To evaluate the 1-year efficacy and safety of treatment with exenatide in combination with insulin (a use not approved by the US Food and Drug Administration). METHODS: Electronic medical records of 3 private-practice endocrinologists were reviewed to identify patients with type 2 diabetes mellitus (T2DM) receiving insulin who subsequently began exenatide therapy. Patients' baseline hemoglobin A1c (A1C) levels, weights, lipid profiles, blood pressures, and medication utilization were compared with corresponding data obtained after a minimal duration of 12 months. RESULTS: We identified 134 patients with T2DM initiating exenatide therapy in combination with insulin between April 2005 and April 2006. One-year follow-up information was available for 124 patients. Exenatide use resulted in a significant 0.87% reduction in A1C (P<.001), despite a 45% discontinuation of premeal insulin use (P<.001), a 9-U reduction in mean premeal insulin doses (P = .0066), a reduction in the median number of daily insulin injections from 2 to 1 (P = .0053), and a 59% discontinuation rate of sulfonylurea use (P = .0088). Exenatide use was associated with a mean weight loss of 5.2 kg (P<.001), with 72% of evaluable patients losing weight. Forty-eight patients (36%) discontinued exenatide therapy during the first year, primarily attributable to gastrointestinal intolerance. Fourteen patients (10%) experienced hypoglycemia, most of which was mild. CONCLUSION: Exenatide in combination with insulin in patients with T2DM was associated with significant reductions in A1C and weight after 1 year of therapy. This was offset, however, by an exenatide discontinuation rate of 36%, primarily due to adverse gastrointestinal effects.